Rapidly insertable central catheters, assemblies, and methods thereof

Abstract

A rapid insertable central catheter (“RICC”), an RICC assembly, and a method thereof are disclosed herein. For example, the RICC may comprise a catheter tube, a suture wing portion disposed over an inner portion of the catheter tube, a hub coupled to a proximal portion of the catheter tube, and a plurality of extension legs extending from the hub. The catheter tube may comprise a first section within a distal portion of the catheter tube and a second section proximal to the first section. The suture wing portion may comprise a projection facing the patient-facing side of the suture wing portion and a needle penetration hole through the projection. The needle penetration hole may be configured to receive a needle for insertion into the primary lumen of the catheter tube, passing through the catheter-tube penetration hole through the suture wing portion. A method of the RICC may include the use of the RICC.

Description

Technology Field

[0001] The present disclosure relates to a rapidly insertable central catheter (“RICC”), an RICC assembly, and a method thereof. Background Technology

[0002] The Seldinger technique utilizes multiple steps and medical devices (e.g., needles, scalpels, guide wires, introduction sheaths, extension devices, etc.) to introduce a central venous catheter ("CVC") into a patient and advance it through the patient's vascular system. While the Seldinger technique is effective, it is time-consuming due to the multiple steps involved and cumbersome due to the handling of numerous medical devices; both of these factors can lead to patient trauma. Furthermore, the risk of touch contamination is relatively high due to the many medical devices that must be replaced during the various steps of the Seldinger technique. Therefore, it is necessary to reduce the number of steps and medical devices involved in introducing a catheter into a patient and advancing it through the patient's vascular system. Prior art literature

[65535] U.S. Patent Publication US 6991625 B2 The problem to be solved

[0003] A rapid-insertable central catheter (“RICC”), a RICC assembly, and a method thereof that solve the above-mentioned problem are disclosed herein. means of solving the problem

[0004] In some embodiments, a rapid insertable central catheter (“RICC”) is disclosed herein, comprising a catheter tube, a suture wing positioned over a medial portion of the catheter tube, a hub coupled to a proximal portion of the catheter tube, and a plurality of extension legs extending from the hub. The catheter tube comprises a first section within a distal portion of the catheter tube and a second section proximal to the first section. The suture wing comprises a projection facing the patient-facing side of the suture wing and a needle penetration hole through the projection. The needle penetration hole is configured to receive a needle for insertion into the primary lumen of the catheter tube, passing through the catheter-tube penetration hole through the suture wing. The number of extension legs is equal to the number of lumens extending through the RICC.

[0005] In some embodiments, the suture wing further comprises a diaphragm disposed within the needle penetration hole. The diaphragm is configured to provide a fluid-tight seal for the needle penetration hole while the needle is positioned within the primary lumen of the catheter tube during percutaneous puncture. The diaphragm is also configured to provide a fluid-tight seal for the needle penetration hole after the needle is withdrawn from the needle penetration hole following percutaneous puncture.

[0006] In some embodiments, a first section of the catheter tube is made of a first polymer material having a first durometer, and a second section of the catheter tube is made of at least one second polymer material having a second durometer lower than the first durometer.

[0007] In some embodiments, each of the first and second polymer materials is polyurethane.

[0008] In some embodiments, the second section comprises an outer layer of the catheter tube extruded over an inner layer of the catheter tube, and accordingly, the outer diameter of the catheter tube is larger in the second section than in the first section.

[0009] In some embodiments, the catheter tube further includes a bump demarcating a third section of the catheter tube proximal to the second section. The third section has an outer diameter larger than both the first and second sections of the catheter tube.

[0010] In some embodiments, the suture wing is positioned over a bump of the catheter tube such that the needle penetration hole is aligned with the needle hole within the catheter tube and the catheter tube proximal to the suture wing has a larger outer diameter than the catheter tube distal to the suture wing.

[0011] In some embodiments, the RICC is a triple lumen catheter comprising a three-pronged hub as a hub and three extension legs extending from the hub. Each of the three extension legs includes a Luer connector coupled to a proximal portion of the extension leg.

[0012] In some embodiments, the RICC comprises a primary lumen extending from an opening in the proximal end of a first Luer connection to an opening in the distal end of a first section of a catheter tube, a secondary lumen extending from an opening in the proximal end of a second Luer connection to a first hole in the distal part of a second section of a catheter tube, and a tertiary lumen extending from an opening in the proximal end of a third Luer connection to a second hole in the distal part of a second section of a catheter tube proximal to the first hole.

[0013] Additionally, in some embodiments, an RICC assembly comprising an RICC and a needle preloaded within the RICC is disclosed herein. The RICC comprises a catheter tube, a suture wing portion disposed over an inner portion of the catheter tube, and a hub coupled to a proximal portion of the catheter tube. The catheter tube comprises a first section within a distal portion of the catheter tube and a second section proximal to the first section. The suture wing portion comprises a projection facing the patient-facing side of the suture wing portion and a needle penetration hole through the projection. The catheter tube passes through the catheter-tube penetration hole through the suture wing portion, and the needle is inserted into the primary lumen of the catheter tube through the needle penetration hole of the suture wing portion.

[0014] In some embodiments, the distal tip of the needle extends past the distal end of the catheter tube for percutaneous puncture using the needle.

[0015] In some embodiments, the RICC assembly further includes a guide wire pre-loaded within the RICC. The guide wire is inserted into the primary lumen of the catheter tube proximal to the point of entry of the needle within the primary lumen of the catheter tube.

[0016] In some embodiments, the suture wing further comprises a diaphragm disposed within the needle penetration hole. The diaphragm is configured to provide a tight seal for the needle penetration hole while the needle is placed within the primary lumen of the catheter tube during percutaneous puncture. The diaphragm is also configured to provide a tight seal for the needle penetration hole after the needle is withdrawn from the needle penetration hole following percutaneous puncture.

[0017] In some embodiments, a first section of the catheter tube is made of a first polymer material having a first durometer, and a second section of the catheter tube is made of at least one second polymer material having a second durometer lower than the first durometer.

[0018] In some embodiments, each of the first and second polymer materials is polyurethane.

[0019] In some embodiments, the second section comprises an outer layer of the catheter tube extruded over an inner layer of the catheter tube, and accordingly, the outer diameter of the catheter tube is larger in the second section than in the first section.

[0020] In some embodiments, the catheter tube further includes a bump that borders a third section of the catheter tube adjacent to a second section. The third section has an outer diameter larger than both the first and second sections of the catheter tube.

[0021] In some embodiments, the suture wing is positioned over a bump of the catheter tube such that the needle penetration hole is aligned with the needle hole within the catheter tube and the catheter tube proximal to the suture wing has a larger outer diameter than the catheter tube distal to the suture wing.

[0022] In some embodiments, the RICC is a triple-lumen catheter comprising a three-pronged hub as a hub and three extension legs extending from the hub. Each of the three extension legs includes a Luer connection coupled to a proximal portion of the extension leg.

[0023] In some embodiments, the RICC comprises a primary lumen extending from an opening in the proximal end of a first Luer connection to an opening in the distal end of a first section of a catheter tube, a secondary lumen extending from an opening in the proximal end of a second Luer connection to a first hole in the distal part of a second section of a catheter tube, and a tertiary lumen extending from an opening in the proximal end of a third Luer connection to a second hole in the distal part of a second section of a catheter tube proximal to the first hole.

[0024] Additionally, a method for introducing an RICC into a patient's vascular lumen is disclosed herein. In some embodiments, this method comprises a RICC assembly-acquisition step, a needle track-construction step, a RICC-advancement step, and a needle-retrieval step. The RICC assembly-acquisition step comprises acquiring a RICC assembly. The RICC assembly comprises a RICC and a needle pre-loaded within the RICC in the introduction-ready state of the RICC assembly. The RICC comprises a catheter tube, a suture wing portion positioned over an inner portion of the catheter tube, and a hub coupled to a proximal portion of the catheter tube. In the introduction-ready state of the RICC assembly, the shaft of the needle extends through a needle penetration hole through the suture wing portion and through the primary lumen of the catheter tube. Additionally, in the introduction-ready state of the RICC assembly, the distal tip of the needle extends beyond the distal end of the catheter tube. The needle track-establishment step includes establishing a needle track from a region of skin to the vascular lumen using the distal tip of the needle. The RICC-advancement step includes advancing the distal portion of the catheter tube over the needle into the vascular lumen. The needle-retrieval step includes retrieving the needle from the RICC through the needle penetration hole of the suture wing.

[0025] In some embodiments, the method further comprises a syringe-connection step and a blood aspiration step. The syringe-connection step is optional in that it includes the step of connecting the syringe to the needle if the syringe is not already connected to the needle in the introduction-ready state of the RICC assembly. The blood aspiration step includes the step of aspirating blood with the syringe prior to the needle retrieval step. The blood aspiration step ensures that the distal tip of the needle is positioned within the vascular lumen.

[0026] In some embodiments, the method further comprises a guide wire-advancement step. The guide wire-advancement step comprises, after the needle-retrieval step, advancing the guide wire into the vascular lumen beyond the distal end of the catheter tube. The guide wire is pre-loaded into the RICC proximal to the needle entry point in the primary lumen of the catheter tube in the introduction-ready state of the RICC assembly.

[0027] In some embodiments, the catheter tube comprises a first section made of a first polymer material having a first durometer, and a second section proximal to the first section, made of at least one second polymer material having a second durometer lower than the first durometer. Accordingly, the catheter tube is configured with a column strength to advance at least the distal portion of the catheter tube into a blood vessel without buckling.

[0028] These and other features of the concept provided herein will become more apparent to those skilled in the art when considering the accompanying drawings and the following description, which more specifically describe specific embodiments of such concept. Brief explanation of the drawing

[0029] FIG. 1 illustrates an assembled, introduction-ready RICC assembly according to some embodiments. FIG. 2 illustrates an RICC assembly in a disassembled state according to some embodiments. FIG. 3 illustrates an RICC in a decomposed state according to some embodiments. FIG. 4 shows an end view of the suture wing portion of RICC according to some embodiments. FIG. 5 shows a side view of the suture wing portion on the catheter tube of RICC according to some embodiments. FIG. 6 illustrates an alternative suture wing-and-hub combination of RICC according to some embodiments. FIG. 7 illustrates the distal portion of the catheter tube of FIG. 3 of the RICC according to some embodiments. FIG. 8a illustrates a transverse cross-section of a first section of a catheter tube according to some embodiments. FIG. 8b illustrates a transverse cross-section of the transition portion between the first and second sections of a catheter tube according to some embodiments. FIG. 8c illustrates a different transverse cross-section of the transition portion between the first and second sections of a catheter tube according to some embodiments. FIG. 8d illustrates a transverse cross-section of a second section of a catheter tube according to some embodiments. FIG. 9 illustrates part of the manufacture of a catheter tube according to some embodiments. Specific details for implementing the invention

[0030] This patent application claims the benefit of priority to U.S. Provisional Application No. 63 / 126,997 filed on December 17, 2020, and the aforementioned U.S. patent application is incorporated by reference into this patent application.

[0031] Before specifically disclosing certain embodiments, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It will also be understood that the specific embodiments disclosed herein may have features that can be easily separated from the specific embodiments and may be optionally combined with or substituted with features of any many other embodiments disclosed herein.

[0032] With respect to the terms used herein, it should be understood that the terms are intended for the purpose of describing certain specific embodiments and do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a group of features or steps and do not provide a sequential or numerical limitation. For example, "first," "second," and "third" features or steps do not necessarily need to appear in such an order, nor is a specific embodiment containing such features or steps necessarily limited to three features or steps. Labels such as "left," "right," "top," "bottom," "front," "rear," etc. are used for convenience and are not intended to imply, for example, any specific fixed position, orientation, or direction. Instead, such labels are used to reflect, for example, relative position, orientation, or direction. Unless otherwise explicitly stated in the context, the singular forms (“a,” “an,” and “the”) include plural objects.

[0033] With respect to "proximal," for example, the "proximal portion" or "proximal end portion" of a catheter disclosed herein comprises the portion of the catheter intended to be close to the clinician when the catheter is used on a patient. Likewise, for example, the "proximal length" of a catheter comprises the length of the catheter intended to be close to the clinician when the catheter is used on a patient. For example, the "proximal end" of a catheter comprises the end of the catheter intended to be close to the clinician when the catheter is used on a patient. The proximal portion, proximal end portion, or proximal length of a catheter may comprise the proximal end of the catheter; however, the proximal portion, proximal end portion, or proximal length of a catheter does not necessarily comprise the proximal end of the catheter. That is, unless otherwise indicated in the context, the proximal portion, proximal end portion, or proximal length of a catheter is not the distal portion or distal length of a catheter.

[0034] With respect to “distal,” for example, the “distal portion” or “distal end portion” of a catheter disclosed herein comprises a portion of the catheter intended to be positioned near or within the patient when the catheter is used against a patient. Likewise, for example, the “distal length” of a catheter comprises a length of the catheter intended to be positioned near or within the patient when the catheter is used against a patient. For example, the “distal end” of a catheter comprises a portion of the catheter intended to be positioned near or within the patient when the catheter is used against a patient. The distal portion, distal end portion, or distal length of the catheter may comprise the distal end of the catheter; however, the distal portion, distal end portion, or distal length of the catheter does not need to comprise the distal end of the catheter. That is, unless otherwise indicated in the context, the distal portion, distal end portion, or distal length of the catheter is not the distal portion or distal length of the catheter.

[0035] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as generally understood by those skilled in the art.

[0036] As previously mentioned, there is a need to reduce the number of steps and medical devices involved in introducing a catheter into a patient and advancing the catheter through the patient's vascular system. An RICC, an RICC assembly, and a method for solving the aforementioned problems are disclosed herein.

[0037] Rapidly insertable central catheter

[0038] FIGS. 1 and 2 illustrate an RICC (100) within an RICC assembly (102) according to some embodiments. FIG. 3 illustrates an RICC (100) in a disassembled state according to some embodiments.

[0039] As described, the RICC (100) includes a catheter tube (104), a suture wing (106), a hub (108), and a plurality of extension legs (110) extending from the hub (108).

[0040] The suture wing portion (106) is positioned over the inner portion of the catheter tube (104) between the proximal and distal portions of the catheter tube (104). The suture wing portion (106) includes a protrusion (112) facing the patient-facing side of the suture wing portion (106), and a needle penetration hole (114) through the protrusion (112). The needle penetration hole (114) is configured to receive a needle (e.g., a needle (150)) through to insert the needle into the primary lumen of the RICC (100), specifically the primary catheter-tube lumen (146) of the catheter tube (104), and the catheter tube (104) passes through the catheter-tube penetration hole (116) through the suture wing portion (106).

[0041] The suture wing portion (106) further comprises a septum (118) placed within the needle penetration hole (114). The septum (118) is configured to provide a tight seal for the needle penetration hole (114) during percutaneous puncture with a needle (e.g., needle (150)) when placed within the primary lumen of the RICC (100) (e.g., the primary catheter-tube lumen (146) of the catheter tube (104)) in the introduction-ready state of the RICC assembly (102) described below, for example. The septum (118) is also configured to provide a tight seal for the needle penetration hole (114) after the needle is withdrawn from the needle penetration hole (114) following percutaneous puncture.

[0042] The suture wing portion (106) includes a pair of wing portions (120) each having a plurality of wing portion penetration holes (122) for fixing the suture wing portion (106) to a patient. Each wing portion of the pair of wing portions (120) may include one wing portion penetration hole, two wing portion penetration holes, three wing portion penetration holes, or four wing portion penetration holes for fixing the suture wing portion (106) to a patient.

[0043] FIG. 6 illustrates an alternative suture wing-and-hub combination (107) of RICC (100) according to some embodiments.

[0044] As described, the suture wing-and-hub combination (107), like the suture wing (106), includes a needle penetration hole (114) configured to receive a needle (e.g., needle (150)) through to insert a needle into the primary lumen of the RICC (100), specifically the primary catheter-tube lumen (146) of the catheter tube (104), and the catheter tube (104) passes through the catheter-tube penetration hole (116) through the suture wing (106).

[0045] Each of the suture wing portion (106) and the suture wing portion-and-hub combination (107) provides a superior advantage over any other RICC currently under development in the use of the RICC (100) in that the needle used to establish a percutaneous perforation with the RICC (100) may be shorter than required with other RICCs. In fact, other RICCs require a relatively long needle placed within the primary lumen that extends from an opening within the proximal end of the other RICC (e.g., an opening in the Luer connection) to an opening within the distal end. With such a long needle, it may take a relatively long time to confirm a flashback of blood after percutaneous perforation using the needle. Furthermore, such a long needle is prone to coagulation within the lumen. However, in RICC (100), the needle may be shorter than required in other RICCs, thereby providing a relatively short time to check for blood flashback after percutaneous puncture using the needle and reducing the risk of coagulation within the lumen of the needle.

[0046] The hub (108) is coupled to the proximal portion of the catheter tube (104), for example, by inserting the proximal portion of the catheter tube (104) into a bore within the distal portion of the hub (108). Although not illustrated, the hub (108) also includes a plurality of bores within the proximal portion of the hub (108) corresponding to the number of extension legs (110). The number of bores within the distal portion of the hub (108) is configured so that a predetermined number of extension legs (110) can be inserted into a predetermined number of bores.

[0047] The RICC (100) may be a single lumen catheter or a multi-lumen catheter, for example, a double lumen catheter, a triple lumen catheter, a quadruple lumen catheter, a quintuple lumen catheter, or a six-lumen catheter. Accordingly, the hub (108) may not branch according to the single lumen catheter, or may branch according to the number of lumens extending through the RICC (100). For example, the hub (108) may be divided into two for the double lumen catheter or into three for the triple lumen catheter. Depending on the selected manufacturing method, the hub (108) may be molded onto a plurality of core pins for a plurality of fluid paths extending longitudinally through the hub (108) configured to fluidly connect a plurality of catheter-tube lumens of the catheter tube (104) to a plurality of extension-leg lumens of a predetermined number of extension legs (110). Alternatively, the hub (108) may be molded onto a plurality of cannulas extending longitudinally through the hub (108) configured to fluidly connect a predetermined number of catheter-tube lumens of the catheter tube (104) to a predetermined number of extension-leg lumens of a predetermined number of extension legs (110).

[0048] Such a number of extension legs (110) extend from the hub (108) through its distal portion. The number of extension legs (110) is equal to the number of lumens extending through the RICC (100). For example: if the RICC (100) is a single-lumen catheter, one extension leg extends from the hub (108). If the RICC (100) is a double-lumen catheter, two extension legs extend from the hub (108). If the RICC (100) is a triple-lumen catheter, three extension legs extend from the hub (108).

[0049] The RICC (100) further comprises a plurality of Luer connections (124) for fluidically connecting a plurality of medical devices to the RICC (100). Each of a predetermined number of extension legs (110) comprises a Luer connection of a predetermined number of Luer connections (124) coupled to a proximal portion of the extension leg. As previously described, the number of Luer connections (124) is equal to the number of extension legs (110), and the number of such extension legs (110) is equal to the number of lumens extending through the RICC (100). For example: if the RICC (100) is a single-lumen catheter, one extension leg extends from the hub (108) and one Luer connection is coupled to one extension leg. If the RICC (100) is a double-lumen catheter, two extension legs extend from the hub (108) and two Luer connections are coupled to each of the two extension legs. If the RICC (100) is a triple-lumen catheter, three extension legs extend from the hub (108) and three Luer connections are coupled to each of the three extension legs.

[0050] The catheter tube (104) comprises at least a first section (126) within a distal portion of the catheter tube (104) and a second section (128) proximal to the first section (126) of the catheter tube (104). The catheter tube (104) may include a transition portion (130) between the first section (126) and the second section (128) of the catheter tube (104), according to the method of manufacturing the catheter tube (104) described below. In fact, according to the manufacturing method described below, the transition portion (130) and the second section (128) of the catheter tube (104) comprise an outer layer (132, see FIG. 8a to FIG. 8d) of the catheter tube (104) extruded over an inner layer (134) of the catheter tube (104) (see FIG. 8a to FIG. 8d), and accordingly, the outer diameter of the catheter tube (104) is larger in the second section (128) than in the first section (126) of the catheter tube (104) starting at the transition portion (130) between the first section (126) and the second section (128) of the catheter tube (104).

[0051] The inner layer (134) of both the first section (126) of the catheter tube (104), as well as the transition portion (130) and the second section (128) of the catheter tube (104), may be formed of a first polymer material having a first durometer (e.g., polytetrafluoroethylene, polypropylene, or polyurethane), while the remainder of the transition portion (130) and the second section (126) of the catheter tube (104), i.e., the outer layer (132), may be formed of a second polymer material having a second durometer having less than the first durometer, greater than the first durometer, or substantially the same as the first durometer (e.g., polyvinyl chloride, polyethylene, polyurethane, or silicone). For example, each layer of the inner layer (134) and the outer layer (132) of the catheter tube (104) may be made of different polyurethanes having different duromites (e.g., the same or different diisocyanates or triisocyanates reacted with different diols or triols, different diisocyanates or triisocyanates reacted with the same or different diols or triols, etc.). Polyurethane is advantageous for the catheter tube (104) in that it may be relatively rigid at room temperature but becomes more flexible at body temperature, which reduces irritation to the blood vessel walls and phlebitis. Polyurethane is also advantageous in that it causes less thrombus formation than some other polymers.

[0052] Notwithstanding the foregoing, the first section (126) and the second section of the catheter tube (104), comprising both the inner layer (134) and the outer layer (132) of the catheter tube (104), may be formed of the same polymer material (e.g., polyurethane) having the same durometer, provided that the column strength of the catheter tube (124) is sufficient to prevent buckling of the catheter tube (104) when it is inserted into the insertion site and advanced through the patient's vascular system. In any given embodiment, the column strength of the catheter tube (104) is noteworthy in that it enables the catheter tube (104) to be rapidly inserted into the insertion site and the catheter tube (104) to be advanced through the patient's vascular system without using the Seldinger technique.

[0053] It should be understood that the first durometer and the second durometer may be of different scales (e.g., Type A or Type D). Therefore, even if the second durometer of the second polymer material is less than the first durometer of the first polymer material, the second durometer may not be numerically smaller than the first durometer. Likewise, even if the second durometer of the second polymer material is greater than the first durometer of the first polymer material, the second durometer may not be numerically larger than the first durometer. That is, because different scales (each ranging from 0 to 100) are designed to characterize different materials within a group of materials having similar durometer values ​​(hardness), the durometer value of the second polymer material may still be smaller or larger than the durometer value of the first polymer material, respectively.

[0054] The catheter tube (104) may include a third section (136) proximal to the second section (128) of the catheter tube (104), which includes a bump diameter bounded by a bumper (138) within the inner portion of the catheter tube (104). The third section (136) of the catheter tube (104) has an outer diameter larger than both the first section (126) and the second section (128) of the catheter tube (104). A suture wing (106) may be placed over the bump (138) as shown in FIGS. 1 and 2 so that the needle penetration hole (114) is aligned with an optional needle hole (140) within the catheter tube (104). Accordingly, the catheter tube (104) proximal to the suture wing (106), referred to herein as the catheter-tube extension, has a larger outer diameter than the catheter tube (104) distal to the suture wing (106). The larger outer diameter of the third section (136) of the catheter tube (104) proximal to the suture wing (106) provides a thicker and larger bend-resistant catheter-tube wall, which is useful for bending the hub (108) and a certain number of extension legs (110) away from the patient's head or neck while the RICC (100) is in use. Additionally, any lumen present within the catheter tube (104) may have a larger diameter within the third section (136) of the catheter tube (104) proximal to the suture wing (106) than within the distal to the suture wing (106). This prevents a decrease in flow, particularly when the third section (136) of the catheter tube (104) proximal to the suture wing (106) is bent away from the patient's head or neck.

[0055] The catheter tube (104) between the suture wing (106) and the hub (108) may have a reverse taper in which the larger outer diameter of the catheter tube (104) continues to increase from the suture wing (106) to the hub (108). In other words, the catheter tube (104) tapers from the hub (108) to the suture wing (106), but still has a larger outer diameter than the catheter tube (104) distal to the suture wing (106). In relation to the continuous increase in the outer diameter of the catheter tube (104) from the suture wing (106) to the hub (108), the thickness of the catheter-tube wall may be continuously increased, the cross-sectional area of ​​any lumen of the catheter tube (104) may be continuously increased, or a combination thereof. Consequently, the catheter tube (104) between the suture wing (106) and the hub (108) may have greater resistance to bending and flow reduction, particularly when the catheter tube (104) proximal to the suture wing (106) is bent away from the patient's head or neck. Notwithstanding the foregoing, the catheter tube (104) between the suture wing (106) and the hub (108) may alternatively have a constant diameter from the suture wing (106) to the hub (108).

[0056] Advantageously, the catheter tube (104) between the suture wing (106) and the hub (108), i.e., the third section (136) of the catheter tube (104) or the catheter-tube extension, is a single catheter tube configured to reduce bacterial penetration between the dressing applied over the suture wing (106) and the patient's skin. Conventional CVCs or peripheral insertion center catheters ("PICCs") have multiple extension legs extending from the suture wing-hub combination common to CVCs and PICCs. Multiple extension legs within a CVC or PICC provide multiple pathways under the dressing through which microorganisms can penetrate. The catheter tube (104), which is at least a single catheter tube between the suture wing (106) and the hub (108), allows the dressing to be fitted around the catheter tube (104) more tightly than is possible with multiple extension legs (110) of a conventional CVC or PICC. For example, the dressing can more easily wrap around the entire circumference of the catheter tube (104) and can be fitted together under the catheter tube (104) between the catheter tube (104) and the patient. In contrast, wrapping a dressing around multiple extension legs of an existing CVC or PICC as described for catheter-tube extensions leaves gaps between adjacent extension tubes through which bacteria can penetrate. Thus, a single catheter tube (104) limits the penetration of bacteria between the dressing applied over the suture wing (106) and the patient's skin.

[0057] The catheter tube (104) between the suture wing (110) and the hub (108), that is, the third section (136) of the catheter tube (104) or the catheter-tube extension, is also configured to alleviate patient discomfort caused by a predetermined number of extension legs (110) being close to the patient's head or neck. As previously described, the third section (136) of the catheter tube (104) proximal to the suture wing (106) provides a thicker and more resistant catheter-tube wall to bend; however, the third section (136) of the catheter tube (104) has sufficient flexibility to allow the catheter tube (104) to bend away from the patient's head or neck and to be secured comfortably to the patient.

[0058] FIG. 7 illustrates the distal portion of the catheter tube (104) of the RICC (100) according to some embodiments. FIGS. 8a through 8d illustrate various transverse cross-sections of the catheter tube (104) according to some embodiments.

[0059] Again, the RICC (100) may be a single lumen catheter or a multi-lumen catheter, for example, a double lumen catheter, a triple lumen catheter, a quadruple lumen catheter, a quintuple lumen catheter, or a six-lumen catheter. Thus, the catheter tube (104) may be a single lumen catheter or a multi-lumen catheter, for example, a double lumen catheter, a triple lumen catheter, a quadruple lumen catheter, a quintuple lumen catheter, or a six-lumen catheter.

[0060] When the RICC (100) is configured as a triple-lumen catheter as illustrated in FIGS. 1 to 3, FIGS. 7, and FIGS. 8a to 8d, the RICC (100) comprises a primary lumen, a secondary lumen, and a tertiary lumen. The primary lumen extends from an opening in the proximal end of a first Luer connection among a predetermined number of Luer connections (124) to an opening in the distal end or tip of a first section (126) of the catheter tube (104). The secondary lumen extends from an opening in the proximal end of a second Luer connection among a predetermined number of Luer connections (124) to a hole (142) in the distal part of a second section (128) of the catheter tube (104). The tertiary lumen extends from an opening in the proximal end of the third Luer connection among a predetermined number of Luer connections (124) to a hole (144) proximal to a hole (142) in the distal part of the second section (128) of the catheter tube (104). Each of the lumens of the primary lumen, secondary lumen, and tertiary lumen is further described in a separate paragraph below.

[0061] The primary lumen of the RICC (100) comprises fluidly connected lumen sections, including a primary catheter-tube lumen (146) extending along the entire length of the catheter tube (104), a primary fluid passage or primary cannula lumen of the hub (108), a primary extension-leg lumen of the first extension leg among a predetermined number of extension leg sections (110), and a primary Luer-connection lumen of the first Luer connection among a predetermined number of Luer connections (124).

[0062] The secondary lumen of the RICC (100) comprises fluidly connected lumen sections including a secondary catheter-tube lumen (148) that extends proximally from a hole (142) in the distal portion of a second section (128) of the catheter tube (104) along the remainder of the catheter tube (104). The fluidly connected lumen sections of the secondary lumen of the RICC (100) further comprise a secondary fluid passage or secondary cannula lumen of the hub (108), a secondary extension-leg lumen of the second extension leg among a predetermined number of extension legs (110), and a secondary Luer-connection lumen of the second Luer connection among a predetermined number of Luer connections (124).

[0063] The tertiary lumen of the RICC (100) comprises fluidly connected lumen sections including a tertiary catheter-tube lumen (149) extending proximally from a hole (144) in the distal portion of the second section (128) of the catheter tube (104) along the remainder of the catheter tube (104). The fluidly connected lumen sections of the tertiary lumen of the RICC (100) further comprise a tertiary fluid passage or tertiary cannula lumen of the hub (108), a tertiary extension-leg lumen of the third extension leg among a predetermined number of extension legs (110), and a tertiary Luer-connection lumen of the third Luer connection among a predetermined number of Luer connections (124).

[0064] When the RICC (100) is configured as a double-lumen catheter, the RICC (100) includes a primary lumen and a secondary lumen. Likewise, when the RICC (100) is configured as a triple-lumen catheter, the primary lumen extends from an opening in the proximal end of the first Luer connection among a predetermined number of Luer connections (124) to an opening in the distal end or tip of the first section (126) of the catheter tube (104). The secondary lumen extends from an opening in the proximal end of the second Luer connection among a predetermined number of Luer connections (124) to a hole (142) in the distal part of the second section (128) of the catheter tube (104). Because the primary lumen and secondary lumen of the RICC (100) configured as a double-lumen catheter are similar to the primary lumen and secondary lumen of the RICC (100) configured as a triple-lumen catheter, additional details regarding each lumen of the primary lumen and secondary lumen of the RICC (100) configured as a double-lumen catheter can be identified from the description above regarding the primary lumen and secondary lumen of the RICC (100) configured as a triple-lumen catheter.

[0065] When the RICC (100) is configured as a single-lumen catheter, the RICC (100) comprises a single lumen, and this single lumen is also referred to herein as the primary lumen in accordance with the description above. Likewise, when the RICC (100) is configured as a triple-lumen catheter, the primary lumen extends from an opening in the proximal end of the first Luer connection among a predetermined number of Luer connections (124) to an opening in the distal end or tip of the first section (126) of the catheter tube (104). Because the primary lumen of the RICC (100) configured as a single lumen type catheter is similar to the primary lumen of the RICC (100) configured as a triple lumen type catheter, additional details regarding the primary lumen of the RICC (100) configured as a single lumen type catheter can be identified from the description above regarding the primary lumen of the RICC (100) configured as a triple lumen type catheter.

[0066] RICC assembly

[0067] FIGS. 1 and FIGS. 2 illustrate an RICC assembly (102) according to some embodiments. In particular, FIG. 1 illustrates an RICC assembly (102) in an assembled introduction-ready state according to some embodiments, whereas FIG. 2 illustrates an RICC assembly (102) in a disassembled state according to some embodiments.

[0068] As illustrated, the RICC assembly (102) comprises at least a RICC (100) and a needle (150) preloaded within the RICC (100) in the introduction-ready state of the RICC assembly (102). Optionally, the RICC assembly (102) comprises a guide wire (152) preloaded within the RICC (100) in the introduction-ready state of the RICC assembly (102), a syringe (154) coupled to the hub of the needle (150), or both the guide wire (152) and the syringe (154). In the packaged state of the RICC assembly (102), the RICC assembly (102) is similar to the introduction-ready state of the RICC assembly (102); however, if the syringe (154) is present within the package containing the RICC assembly (102), it is not necessary to couple the syringe (154) to the hub of the needle (150). In fact, the syringe (154) can be packaged along the remainder of the RICC assembly (102) in the packaged state of the RICC assembly (102).

[0069] The needle (150) is inserted into the primary lumen of the RICC (100) through the needle penetration hole (114) of the suture wing portion (106) in the introduction-ready state of the RICC assembly (102). Specifically, the needle (150) is inserted into the primary catheter-tube lumen (146) of the catheter tube (104), and the catheter tube (104) passes through the catheter-tube penetration hole (116) through the suture wing portion (106). Additionally, the distal tip of the needle (150), including a bevel, extends past the distal end of the catheter tube (104) for percutaneous perforation using the needle (150).

[0070] The guide wire (152) is inserted into the primary lumen of the RICC (100) through an opening in the proximal end of the first Luer connection among a predetermined number of Luer connections (124) in the introduction-ready state of the RICC assembly (102). The distal end of the guide wire (152) is positioned proximal to the entry point of the needle (150) in the primary lumen of the RICC (100), specifically in the primary catheter-tube lumen (146) of the catheter tube (104). Positioning the guide wire (152) in this way in the introduction-ready state of the RICC assembly (102) allows the guide wire (152) to be immediately advanced into the patient's vascular lumen after percutaneous puncture using the needle (150) and retrieval of the needle from the RICC (100). Deploying the guide wire (152) as described above in the introduction-ready state of the RICC assembly (102) is more advantageous than deploying the guide wire (152) within the needle (150) because the guide wire (152) can have a larger diameter than that allowed by the needle (150), and this larger diameter provides greater stability for the catheter tube (104) when operated over the guide wire (152).

[0071] method

[0072] The above-described method of the RICC and RICC assembly includes a method of manufacturing and using the RICC and RICC assembly. An exemplary method for manufacturing the RICC (100) is described below by the method of using the RICC assembly (102), specifically by introducing the RICC (100) into the vascular lumen of a patient.

[0073] A method for manufacturing an RICC (100) comprises one or more catheter tube-manufacturing steps for manufacturing a catheter tube (104), one or more extrusion steps for extruding one or more extrudable components other than the catheter tube (104), such as a predetermined number of extension legs (110), one or more molding steps for molding one or more moldable components, and one or more assembly steps for assembling the RICC (100) or any part thereof by coupling together the extrudable components including the catheter tube (104) and the moldable components.

[0074] FIG. 9 illustrates part of the manufacture of a catheter tube (104) according to some embodiments.

[0075] One or more catheter tube-manufacturing steps include an inner-layer forming step. The inner-layer forming step includes forming an inner layer (134) of the catheter tube (104) by extruding a single lumen-shaped tubing (156) of the first polymer material.

[0076] One or more catheter tube-manufacturing steps further include an insertion step. The insertion step includes inserting the end of a single lumen-shaped tubing (156) through the die (158) of an extruder (160).

[0077] One or more catheter tube-manufacturing steps further include a second-layer forming step. The second-layer forming step includes forming an outer layer (132) of the catheter tube (104) by periodically forcing a melt (162) of the second polymer material through a die (158) around a monoluminal tubing (156), thereby forming an output tubing having sections of mixed-layer tubing (164) regularly interspersed with sections of monoluminal tubing (156).

[0078] One or more catheter tube-manufacturing steps further include a bonding layer-application step. The bonding layer-application step includes the step of applying a bonding layer over a single-lumen tubing (156) before forcing a melt (162) of the second polymer material through a die (158) around the single-lumen tubing (156) in the second-layer forming step.

[0079] One or more catheter tube manufacturing steps further include a lumen forming step. The lumen forming step includes forming one or more additional lumens (e.g., a secondary catheter-tube lumen (148), a tertiary catheter-tube lumen (149), etc.) in the lumen of the single lumen tubing (156) by injecting air into the melt of the second polymer material (162) while forcing the melt of the second polymer material (162) around the single lumen tubing (156) through the die (158).

[0080] One or more catheter tube-manufacturing steps further include a bump-forming step. The bump-forming step includes creating one or more holes (e.g., needle hole (140), hole (142), hole (144), etc.) within a section of the mixed-layer tubing (164) and thereby forming one or more openings in the primary catheter-tube lumen (146) or one or more additional lumens.

[0081] One or more catheter tube-manufacturing steps may further include a bump-forming step. The bump-forming step includes forming a bump (e.g., a bump (138) in the inner part of the catheter tube (104)) within a section of the mixed-layer tubing (164) by periodically slowing down the speed at which the output tubing is pulled by the pull portion to increase the outer diameter of the output tubing after the bump.

[0082] One or more catheter tube-manufacturing steps may further include a reverse tapering step. The reverse tapering step includes the step of reverse tapering the outer diameter within a section of the mixed-layer tubing (164) after the bump by continuously slowing down the speed at which the output tubing is pulled by the pull portion.

[0083] One or more catheter tube-manufacturing steps may further include a cooling step. The cooling step includes the step of pulling the output tubing through a cooling bath with a puller to cool the output tubing.

[0084] One or more catheter tube-manufacturing steps further include a cutting step. The cutting step includes the step of using a cutter to cut the output tubing within a section of at least a single lumen-shaped tubing (156) to form a catheter tube such as a catheter tube (104).

[0085] One or more extrusion steps may include a step of extruding any one or more of the extended legs (110) among a predetermined number of extended legs according to the description above for one or more extended legs.

[0086] One or more molding steps may include a step of molding any one or more moldable components selected from the sutured wing portion (106) and the hub (108) according to the description above regarding the moldable components. One or more molding steps may further include a step of molding any one or more lure connections among a predetermined number of lure connections (124) according to the description above regarding one or more lure connections.

[0087] One or more assembly steps for assembling the RICC (100) or any part thereof may include the step of assembling the RICC (100) as illustrated in FIG. 3, with an understanding that the distal part of the catheter tube (104) is inserted into the proximal part of the suture wing (106).

[0088] A method for introducing RICC (100) into the vascular lumen of a non-human subject includes an RICC assembly-obtaining step, a needle track-building step, first and second RICC-advancement steps, and a needle-retrieval step.

[0089] The RICC assembly-acquisition step includes the step of acquiring the RICC assembly (102). As previously described, the RICC assembly (102) comprises at least the RICC (100) and a needle (150) that is pre-loaded within the RICC in the introduction-ready state of the RICC assembly (102). In effect, the shaft of the needle (150) extends through the needle penetration hole (114) of the suture wing portion (106) and the primary lumen of the RICC (100), specifically the primary catheter-tube lumen (146) of the catheter tube (104) in the introduction-ready state of the RICC assembly (102). Additionally, in the introduction-ready state of the RICC assembly (102), the distal tip of the needle (150) extends beyond the distal end of the catheter tube (104).

[0090] The needle tract-establishing step includes the step of establishing a needle tract from a region of skin to a vascular lumen using the distal tip of the needle (150).

[0091] The first RICC-advancement step includes the step of advancing the distal portion of the catheter tube (104) into the vascular lumen over the needle (150).

[0092] The needle-retrieval step includes the step of retrieving the needle (150) from the RICC (100) through the needle penetration hole (114) of the suture wing portion (106).

[0093] The second RICC-advancement step includes the step of advancing the catheter tube (104) through the patient's vascular system without the need to use the Seldinger technique. For example, if the insertion site is the right subclavian vein or the right internal jugular vein, the second RICC-advancement step may include the step of advancing the catheter tube (104) further into the insertion site so that the catheter tube (104), or at least its distal portion, is advanced through the right subclavian vein or the right internal jugular vein, the right brachiocephalic vein, and into the superior vena cava. Other insertion sites, such as the left subclavian vein or the left internal jugular vein, require advancing the distal portion of the catheter tube (104) through the corresponding vascular system. The Seldinger technique is not necessary because the catheter tube (104) has sufficient column strength to prevent buckling of the catheter tube (104) when it is inserted into the insertion site and advanced through the patient's vascular system.

[0094] The method may further include a syringe-connecting step and a blood-aspirating step. The syringe-connecting step is optional in that it includes the step of connecting the syringe (154) to the hub of the needle (150) if the syringe (154) is not already connected to the needle (150) in the introduction-ready state of the RICC assembly (102). The blood-aspirating step includes the step of aspirating blood with the syringe (154) prior to the needle-retrieval step. The blood-aspirating step ensures that the distal tip of the needle (150) is positioned within the patient's vascular lumen.

[0095] The method may further include a guide wire-advancement step after the needle-withdrawing step. The guide wire-advancement step includes, after the needle-withdrawing step, advancing the guide wire (152) beyond the distal end of the catheter tube (104) into the patient's vascular lumen. As described above, the guide wire (152) is pre-loaded in the RICC (100) proximal to the entry point of the needle (150) in the primary lumen of the RICC (100), specifically in the primary catheter-tube lumen (146) of the catheter tube (104), in the introduction-ready state of the RICC assembly (102).

[0096] While certain specific embodiments have been disclosed herein and some specific embodiments have been disclosed in some detail, such specific embodiments are not intended to limit the scope of the concept provided herein. Further adaptations and / or modifications may be made by those skilled in the art, and, in a broader sense, such adaptations and / or modifications are also included. Accordingly, adaptations and / or modifications may be made from the specific embodiments disclosed herein without departing from the scope of the concept provided herein.

Claims

Claim 1 A rapid insertable central catheter (“RICC”) comprising: a catheter tube—the catheter tube comprises a first section within a distal portion of the catheter tube; and a second section proximal to the first section—; a suture wing portion disposed over an inner portion of the catheter tube—the suture wing portion comprises a projection facing the patient-facing side of the suture wing portion; and a needle penetration hole through the projection configured to receive the needle for inserting the needle into a primary lumen of the catheter tube passing through a catheter-tube penetration hole through the suture wing portion—; a hub coupled to a proximal portion of the catheter tube; and a plurality of extension legs extending from the hub, the number of which is equal to the number of lumens extending through the RICC. Claim 2 RICC according to claim 1, wherein the suture wing portion further comprises a septum disposed within the needle penetration hole, and the septum is configured to provide a tight seal for the needle penetration hole during or after percutaneous puncture while the needle is disposed within the primary lumen of the catheter tube, or after the needle is retrieved from the needle penetration hole. Claim 3 RICC according to claim 1 or 2, wherein the first section of the catheter tube is made of a first polymer material having a first durometer, and at least a portion of the second section of the catheter tube is made of a second polymer material having a second durometer lower than the first durometer. Claim 4 In paragraph 3, RICC, wherein each of the first and second polymer materials is polyurethane. Claim 5 In claim 1 or 2, the second section comprises an outer layer of the catheter tube extruded over an inner layer of the catheter tube, and accordingly, the outer diameter of the catheter tube is larger in the second section than in the first section, RICC. Claim 6 In claim 1 or 2, the catheter tube further comprises a bump demarcating a third section of the catheter tube proximal to the second section, wherein the third section has an outer diameter larger than both the first and second sections of the catheter tube, RICC. Claim 7 In claim 6, the suture wing is positioned over a bump of the catheter tube such that the needle penetration hole is aligned with the needle hole in the catheter tube and the catheter tube proximal to the suture wing has a larger outer diameter than the catheter tube distal to the suture wing, RICC. Claim 8 The RICC according to claim 1 or 2 is a triple lumen catheter comprising a three-pronged hub as a hub and three extension legs extending from the hub, wherein each of the three extension legs comprises a Luer connector coupled to a proximal portion of the extension leg. Claim 9 In claim 8, the RICC comprises a primary lumen extending from an opening in the proximal end of a first Luer connection to an opening in the distal end of the first section of the catheter tube, a secondary lumen extending from an opening in the proximal end of a second Luer connection to a first hole in the distal part of the second section of the catheter tube, and a tertiary lumen extending from an opening in the proximal end of a third Luer connection to a second hole in the distal part of the second section of the catheter tube proximal to the first hole. Claim 10 A rapid insertable central catheter ("RICC") assembly comprising: a RICC; and a needle preloaded within the RICC, wherein the RICC comprises: a catheter tube—the catheter tube comprises a first section within a distal portion of the catheter tube; and a second section proximal to the first section—; a suture wing portion disposed over an inner portion of the catheter tube—the suture wing portion comprises a projection facing the patient-facing side of the suture wing portion; and a needle penetration hole through the projection—the catheter tube passes through the catheter-tube penetration hole through the suture wing portion—; and a hub coupled to a proximal portion of the catheter tube; wherein the needle is inserted into the primary lumen of the catheter tube through the needle penetration hole of the suture wing portion. Claim 11 In paragraph 10, the distal tip of the needle extends past the distal end of the catheter tube for percutaneous perforation using the needle, forming a RICC assembly. Claim 12 A RICC assembly according to claim 10 or 11, further comprising a guide wire pre-loaded within the RICC, wherein the guide wire is inserted into the primary lumen of the catheter tube proximal to the entry point of the needle within the primary lumen of the catheter tube. Claim 13 A RICC assembly according to claim 10 or 11, wherein the suture wing portion further comprises a diaphragm disposed within the needle penetration hole, and the diaphragm is configured to provide a tight seal for the needle penetration hole during or after the needle is withdrawn from the needle penetration hole while the needle is disposed within the primary lumen of the catheter tube. Claim 14 A RICC assembly according to claim 10 or 11, wherein the first section of the catheter tube is made of a first polymeric material having a first durometer, and at least a portion of the second section of the catheter tube is made of a second polymeric material having a second durometer lower than the first durometer. Claim 15 In paragraph 14, a RICC assembly in which each of the first and second polymer materials is polyurethane. Claim 16 RICC assembly according to claim 10 or 11, wherein the second section comprises an outer layer of the catheter tube extruded over an inner layer of the catheter tube, and accordingly, the outer diameter of the catheter tube is larger in the second section than in the first section. Claim 17 RICC assembly according to claim 10 or 11, wherein the catheter tube further comprises a bump demarcating a third section of the catheter tube proximal to the second section, and the third section has an outer diameter larger than both the first and second sections of the catheter tube. Claim 18 A RICC assembly according to claim 17, wherein the suture wing is positioned over a bump of the catheter tube such that the needle penetration hole is aligned with the needle hole in the catheter tube and the catheter tube proximal to the suture wing has a larger outer diameter than the catheter tube distal to the suture wing. Claim 19 In claim 10 or 11, the RICC is a triple-lumen catheter comprising a three-pronged hub as a hub and three extension legs extending from the hub, and each of the three extension legs comprises a Luer connection coupled to a proximal portion of the extension leg, RICC assembly. Claim 20 In claim 19, the RICC assembly comprises: a primary lumen extending from an opening in the proximal end of a first Luer connection to an opening in the distal end of the first section of the catheter tube; a secondary lumen extending from an opening in the proximal end of a second Luer connection to a first hole in the distal part of the second section of the catheter tube; and a tertiary lumen extending from an opening in the proximal end of a third Luer connection to a second hole in the distal part of the second section of the catheter tube proximal to the first hole. Claim 21 A method for introducing a rapid-insertable central catheter ("RICC") into the vascular lumen of a non-human subject, comprising the steps of: acquiring a RICC assembly, wherein the RICC assembly comprises a catheter tube, a suture wing portion disposed over an inner portion of the catheter tube, and a hub coupled to a proximal portion of the catheter tube; and a needle preloaded within the RICC in a ready-to-introduce state of the RICC, a shaft of the needle extending through a needle penetration hole through the suture wing portion and through the primary lumen of the catheter tube, and a distal tip of the needle extending beyond a distal end of the catheter tube; constructing a needle track from a region of skin to the vascular lumen with the distal tip of the needle; and advancing the distal portion of the catheter tube into the vascular lumen over the needle. A method comprising the step of retrieving the needle from the RICC through the way of the needle penetration hole of the suture wing portion. Claim 22 A method according to claim 21, further comprising: connecting the syringe to the needle when the syringe is not already connected to the needle in the introduction-ready state of the RICC assembly; and aspirating blood with the syringe before retrieving the needle from the RICC to check whether the distal tip of the needle is positioned within the vascular lumen. Claim 23 A method according to claim 21 or 22, further comprising, after the step of retrieving the needle from the RICC, the step of advancing a guide wire into the vascular lumen beyond the distal end of the catheter tube, wherein the guide wire is pre-loaded in the RICC proximal to the point of entry of the needle in the primary lumen of the catheter tube in the introduction-ready state of the RICC assembly. Claim 24 A method according to claim 21 or 22, wherein the catheter tube comprises a first section made of a first polymer material having a first durometer, and a second section proximal to the first section made of at least a second polymer material having a second durometer lower than the first durometer, and thereby the catheter tube is configured with a column strength to advance the distal portion of the catheter tube into the vascular lumen without buckling.

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